Marathon Pharmaceuticals on Monday said it would pause the launch of its Duchenne muscular dystrophy drug following criticism over the treatment's $89,000 price tag, reports Reuters.
Here are six things to know.
1. While the Food and Drug Administration last week approved Emflaza as the second treatment for the rare condition, the drug — generically known as deflazacort — can be imported from other countries for as little as $1,000 a year.
2. Marathon CFO Babar Ghias told The Washington Post the net price of the drug will be about $54,000 a year after rebates and discounts. For patients, the cost of the drug would be "zero or low out-of-pocket expense" when considering insurance and financial assistance programs from the company, according to the report.
3. Senator Bernie Sanders, I-Vt., and Congressman Elijah Cummings, D-Md., on Monday sent a letter to Marathon CEO Jeffrey Aronin calling out the company for the price of Emflaza. Since Marathon did not develop the drug — which has been around for decades — the lawmakers asked the company to justify Emflaza's $89,000 price tag by documenting the costs associated with bringing the drug to market, according to Reuters.
4. The lawmakers also scrutinized the drug's orphan drug designation, which gives Marathon seven years of exclusive rights to sell Emflaza in the U.S.
"Marathon will have a monopoly on deflazacort for years to come, preventing less expensive generic competitors from entering the market, despite the fact that this drug is already available in generic form in other countries," Sanders and Cummings wrote in the letter.
5. Shortly after Mr. Aronin received the letter Monday, he issued a statement on the patient advocacy website Cure Duchenne saying the company would hold off on launching the drug amid "concerns about how the pricing and reimbursement details will affect individual patients and caregivers."
6. Despite postponing Emflaza's launch, the company will maintain its expanded access program, which supplies the drug to 800 patients at no cost and said patients currently importing the drug from overseas will still be able to, reports Reuters.
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